WEB™

Main information

  • Trade name:
  • WEB™ Aneurysm Embolisation System - Prosthesis, internal, embolization, intravascular
  • Class:
  • Class III
  • Medicine domain:
  • Humans
  • Medicine type:
  • Medical device

Documents

Localization

  • Available in:
  • WEB™ Aneurysm Embolisation System - Prosthesis, internal, embolization, intravascular
    Australia
  • Language:
  • English

Other information

Status

  • Source:
  • Dept. of Health,Therapeutic Goods Administration - Australia
  • Authorization number:
  • 218415
  • Last update:
  • 08-10-2017

Public Assessment Report

Public Summary

Summary for ARTG Entry:

218415

Culpan Medical Pty Ltd - WEB™ Aneurysm Embolisation System - Prosthesis, internal, embolization,

intravascular

ARTG entry for

Medical Device Included Class III

Sponsor

Culpan Medical Pty Ltd

Postal Address

PO Box 114,PYRMONT, NSW, 2009

Australia

ARTG Start Date

12/12/2013

Product category

Medical Device Class III

Status

Active

Approval area

Medical Devices

Conditions

- The inclusion of the kind of device in the ARTG is subject to compliance with all conditions placed or imposed on the ARTG entry. Refer Part 4-5,

Division 2 (Conditions) of the Therapeutic Goods Act 1989 and Part 5, Division 5.2 (Conditions) of the Therapeutic Goods (Medical Devices) Regulations

2002 for relevant information.

- Breaching conditions of the inclusion related to the device of the kind may lead to suspension or cancellation of the ARTG entry; may be a criminal

offence; and civil penalties may apply.

Manufacturers

Name

Address

Sequent Medical Inc

11A Columbia Aliso Viejo

, CA, 92656

United States Of America

Products

1. WEB™ Aneurysm Embolisation System - Prosthesis, internal, embolization, intravascular

Product Type

Single Device Product

Effective date

12/12/2013

GMDN

35449 Prosthesis, internal, embolization, intravascular

Functional description

The WEB Aneurysm Embolization System consists of an implantable embolization device attached to a

delivery device. The device is manufactured from nitinol wires in a braided, self-expanding mesh

configuration available in a broad range of diameters and lengths to meet the specific needs of the patient.

The device is separated from the delivery device by the use of a separate battery-powered detachment

control device. The device is supplied sterile and is single use.

Intended purpose

The WEB™ Aneurysm Embolization System is intended for the endovascular embolization of ruptured and

unruptured intracranial aneurysms and other neurovascular abnormalities such as arteriovenous fistulae

(AVF). The WEB™ Aneurysm Embolization System is also intended for vascular occlusion of blood

vessels within the neurovascular system to permanently obstruct blood flow to an aneurysm or other

vascular malformation.

Variant information

Shape Barrel

Shape Sphere

Diameter (mm) 4-11

Height (mm) 2.6-9.6

Specific Conditions

No Specific Conditions included on Record

© Commonwealth of Australia.This work is copyright.You are not permitted to re-transmit, distribute or commercialise the material without obtaining prior

written approval from the Commonwealth.Further details can be found at http://www.tga.gov.au/about/website-copyright.htm.

Public Summary

Page 1 of

Produced at 10.11.2017 at 10:33:03 AEDT

This is not an ARTG Certificate document.

The onus is on the reader to verify the current accuracy of the information on the document subsequent to the date shown.

Visit www.tga.gov.au for contact information

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